Stilnoct 5mg Film-Coated Tablets

The Summary of Product Characteristics (SPC or SmPC) is a specific document, the wording of which has been agreed with the regulatory authority as part of the medicine approval process. It is required before any medicine is allowed on the market in Europe. It is designed to assist doctors and pharmacists in prescribing and supplying the product.

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 25 March 2020 SmPC

Reasons for updating

Improved presentation of SmPC

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 19 March 2020 SmPC

Reasons for updating

Change to section 4.2 - Posology and method of administration

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.8 - Undesirable effects

Change to section 6.5 - Nature and contents of container

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 19 March 2020 PIL

Reasons for updating

Change to section 4 - possible side effects

Change to section 4 - how to report a side effect

Change to section 6 - what the product contains

Change to section 6 - what the product looks like and pack contents

Free text change information supplied by the pharmaceutical company

Updated on 9 May 2019 PIL

Reasons for updating

Change to section 2 - what you need to know - warnings and precautions

Updated on 8 May 2019 SmPC

Reasons for updating

Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.4 Special warnings and precautions for use

Suicidal ideation/suicide attempt/suicide and depressionSome epidemiological studies suggest an increased incidence of suicidal ideation, suicide attempt and suicide in patients with or without depression, and treated with benzodiazepines and other hypnotics, including zolpidem. However, a causal relationship has not been established.

Updated on 22 January 2019 PIL

Reasons for updating

Change to Section 1 - what the product is

Change to section 1 - what the product is used for

Change to section 2 - what you need to know - warnings and precautions

Updated on 22 January 2019 SmPC

Reasons for updating

Change to section 4.2 - Posology and method of administration

Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The duration of treatment should usually vary from a few days to two weeks with a maximum of four weeks including tapering off where clinically appropriate.

Treatment should be as short as possible. It should not exceed four weeks including the period of tapering off. In certain cases extension beyond the maximum treatment period may be necessary; if so, extension beyond the maximum treatment period should not take place without re-evaluation of the patient's status, since the risk of abuse and dependence increases with the duration of treatment (see Section 4.4).

DependenceUse of zolpidem may lead to the development of abuse and/or physical and psychological dependence. The risk of dependence increases with dose and duration of treatment. The risk of abuse and dependence is also greater in patients with a history of psychiatric disorders and/or alcohol, substance or drug abuse. zolpidem should be used with extreme caution in patients with current or a history of alcohol, substance or drug abuse or dependence. If physical dependence is developed, a sudden discontinuation of treatment will be accompanied by withdrawal symptoms. These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases the following symptoms may occur: derealisation, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.Precautions:

Updated on 23 November 2018 PIL

Reasons for updating

Change to section 2 - pregnancy, breast feeding and fertility

Updated on 23 November 2018 SmPC

Reasons for updating

Change to section 4.6 - Pregnancy and lactation

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.6 Fertility, pregnancy and lactation

Pregnancy

The use of zolpidem is not recommended during pregnancy.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

Zolpidem crosses the placenta.

A large amount of data on pregnant women (more than 1000 pregnancy outcomes) collected from cohort studies has not demonstrated evidence of the occurrence of malformations following exposure to benzodiazepines or benzodiazepine-like substances during the first trimester of pregnancy. However, certain case-control studies reported an increased incidence of cleft lip and palate associated with use of benzodiazepines during pregnancy.

Cases of reduced foetal movement and foetal heart rate variability have been described after administration of benzodiazepines or benzodiazepine-like substances during the second and/or third trimester of pregnancy. Administration of zolpidem during the late phase of pregnancy or during labour has been associated with effects on the neonate, such as hypothermia, hypotonia, feeding difficulties (‘floppy infant syndrome’), and respiratory depression, due to the pharmacological action of the product. Cases of severe neonatal respiratory depression have been reported.

Moreover, infants born to mothers who took sedative/hypnotic agents chronically during the latter stages of pregnancy may have developed physical dependence and may be at risk of developing withdrawal symptoms in the postnatal period. Appropriate monitoring of the newborn in the postnatal period is recommended.

If Stilnoct is prescribed to a woman of childbearing potential, she should be warned to contact her physician about stopping the product if she intends to become or suspects that she is pregnant.As a precautionary measure, it is preferable to avoid the use of zolpidem in pregnancy.

For zolpidem, no or very limited amount of data on pregnant patients are available. Animal studies do not indicate direct harmful effects with respect to reproduction toxicity development.

If the product is prescribed to a woman of childbearing potential, she should be warned to contact her physician about stopping the product if she intends to become or suspects that she is pregnant.

If zolpidem is administered during the late phase of pregnancy, or during labour, effects on the neonate, such as hypothermia, hypotonia and moderate respiratory depression, can be expected due to the pharmacological action of the product. Cases of severe neonatal respiratory depression have been reported when zolpidem was used with other CNS depressants at the end of pregnancy.

Moreover, infants born to mothers who took sedative/hypnotic agents chronically during the latter stages of pregnancy may have developed physical dependence and may be at some risk of developing withdrawal symptoms in the postnatal period.

Lactation

Small quantities of zolpidem appear in breast milk. The use of zolpidem in nursing mothers is therefore, not recommended.

4.7 Effects on ability to drive and use machines

Updated on 19 September 2018 SmPC

Reasons for updating

Improved presentation of SmPC

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 18 September 2018 PIL

Reasons for updating

Improved presentation of PIL

Updated on 4 January 2018 SmPC

Reasons for updating

New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 4 January 2018 SmPC

Reasons for updating

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 added:-

Risk from concomitant use of opioids:

Concomitant use of Stilnoct and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of sedative medicines such as benzodiazepines or related drugs such as Stilnoct with opioids should be reserved for patients for whom alternative treatment options are not possible.

If a decision is made to prescribe Stilnoct concomitantly with opioids, the lowest effective dose should be used, and the duration of treatment should be as short as possible (see also general dose recommendation in section 4.2).

The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their environment to be aware of these symptoms (see section 4.5).

Section 4.5 added:-

Opioids:

The concomitant use of sedative medicines such as benzodiazepines or related drugs such as Stilnoct with opioids increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dosage and duration of concomitant use should be limited (see section 4.4).

Updated on 22 December 2017 PIL

Reasons for updating

New PIL for new product

Updated on 22 December 2017 PIL

Reasons for updating

Change to section 2 - what you need to know - warnings and precautions

Updated on 22 November 2017 PIL

Reasons for updating

Change to section 3 - how to take/use

Change to section 6 - date of revision

Updated on 10 July 2017 SmPC

Reasons for updating

Change to section 4.4 - Special warnings and precautions for use

Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The change involves an update to section 4.4 of the SPC to include reference to the following:

• Suicidality

• Patients with Long QT syndrome

Updated on 3 July 2017 PIL

Reasons for updating

Change to section 2 - what you need to know - warnings and precautions

Change to section 6 - date of revision

Updated on 26 June 2017 SmPC

Reasons for updating

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Change to Section 4.8 – Undesirable effects - how to report a side effect

Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

CCDS v11

The change involves an update to sections 4.5 and 4.8 of the SmPCs namely:

Section 2 and Section 4 of the PIL has been updated accordingly to reflect the SmPC updates.

Updated on 20 June 2017 PIL

Reasons for updating

Change to section 2 - interactions with other medicines, food or drink

Change to section 4 - possible side effects

Change to section 6 - date of revision

Updated on 30 August 2016 PIL

Reasons for updating

Change to, or new use for medicine

Change to instructions about missed dose

Change to instructions about overdose

Change to side-effects

Updated on 19 August 2016 SmPC

Reasons for updating

Change to section 4.1 - Therapeutic indications

Change to section 4.2 - Posology and method of administration

Change to section 4.3 - Contraindications

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.8 - Undesirable effects

Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

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Updated on 18 August 2016 PIL

Reasons for updating

Change to date of revision

Updated on 5 January 2015 SmPC

Reasons for updating

Change to section 4.2 - Posology and method of administration

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Change to section 4.7 - Effects on ability to drive and use machines

Change to section 5.1 - Pharmacodynamic properties

Change to section 6.3 - Shelf life

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

﻿Section 4.2 updated:

The recommended daily dose for adults is 10 mg.

The treatment should be taken in a single intake and not be re-administered during the same night.The recommended daily does for adults is 10mg to be taken immediately at bedtime.The lowest effective daily dose of zolpidem should be used and must not exceed 10mg.

Section 4.4:
New paragraph:

Next-day psychomotor impairment

The risk of next-day psychomotor impairment, including impaired driving ability, is increased if:

• zolpidem is taken within less than 8 hours before performing activities that require mental alertness (see section 4.7);

• a dose higher than the recommended dose is taken;

• zolpidem is co-administered with other CNS depressants or with other drugs that increase the blood levels of zolpidem, or with alcohol or illicit drugs (see section 4.5).

Zolpidem should be taken in a single intake immediately at bedtime and not be re-administered during the same night.

Amnesia changed:

Amnesia:

Sedative/hypnotic agents such as zolpidem may induce anterograde amnesia.The condition occurs most often several hours after ingesting the product and therefore to reduce the risk patients should ensure that they will be able to have an uninterrupted sleep of 7-8 hours. In order to reduce the risk, patients should ensure that they will be able to have an uninterrupted sleep of 8 hours (see section 4.8).

Due to its pharmacological properties, zolpidem can cause drowsiness and a decreased level of consciousness, which may lead to falls and consequently to severe injuries, see also section 4.8.

Section 4.5: changes:

Combination with CNS depressants.

Enhancement of the central depressive effect may occur in cases of concomitant use with antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressant agents, narcotic analgesics, antiepileptic drugs, anaesthetics and sedative antihistamines. Therefore concomitant use of zolpidem with these drugs may increase drowsiness and next day psychomotorimpairment, including impaired driving ability (see section 4.4 and section 4.7).Also, isolated cases of visual hallucinations were reported in patients taking zolpidem with antidepressants including buproprion, desipramine, fluoxetine, sertraline and venlafaxine..

Co- administration of fluvoxamine may increase blood levels of zolpidem, concurrent use is not recommended. However, in the case of SSRI antidepressant agents (fluoxetine and sertraline), no clinically significant pharmacokinetic or pharmacodynamic interactions have been observed.

Co-administration ciprofloxacin may increase blood levels of zolpidem, concurrent use is not recommended.

Other drugs: When zolpidem was administered with warfarin, digoxin, ranitidine or cimetidine, no significant pharmacokinetic interactions were observed.

Section 4.7:

Vehicle drivers and machine operators should be warned that, as with other hypnotics, there may be a possible risk of drowsiness the morning after therapy. In order to minimise this risk a full night sleep (7-8 hours) is recommended.

Stilnoct has major influence on the ability to drive and use machines.

Vehicle drivers and machine operators should be warned that, as with other hypnotics, there may be a possible risk of drowsiness, prolonged reaction time, dizziness, sleepiness, blurred/double vision and reduced alertness and impaired driving the morning after therapy (see section 4.8). In order to minimise this risk a resting period of at least 8 hours is recommended between taking zolpidem and driving, using machinery and working at heights.

Driving ability impairment and behaviours such as ‘sleep-driving’ have occurred with zolpidem alone at therapeutic doses.

Furthermore, the co-administration of zolpidem with alcohol and other CNS depressants increases the risk of such behaviours (see section 4.4 and 4.5). Patients should be warned not to use alcohol or other psychoactive substances when taking zolpidem.

Section 4.8 changes:

General Disorders and administration site conditions

Common: fatigue

Not known: gait disturbance, drug tolerance, fall (predominantly in elderly patients and when zolpidem was not taken in accordance with prescribing recommendation. (Seesection 4.4Special warnings and precautions for use)

The randomized trials only showed convincing evidence of efficacy of 10mg zolpidem.

In a randomized double-blind trial in 462 non-elderly healthy volunteers with transient insomnia, zolpidem 10mg decreased the mean time to fall asleep by 10 minutes compared to placebo, while for 5mg zolpidem this was 3 minutes.

In a randomized double-blind trial in 114 non-elderly patients with chronic insomnia, zolpidem 10mg decreased the mean time to fall asleep by 30 minutes compared to placebo, while for 5mg zolpidem this was 15 minutes.

In some patients, a lower dose of 5mg could be effective

Section 6.3: Shelf life reduced to 3 years.

Updated on 19 December 2014 PIL

Reasons for updating

Change to warnings or special precautions for use

Change to side-effects

Change to drug interactions

Change to information about driving or using machinery

Change to how the medicine works

Change to date of revision

Updated on 27 February 2013 SmPC

Reasons for updating

Change to section 4.4 - Special warnings and precautions for use

Change to section 4.6 - Pregnancy and lactation

Change to section 4.8 - Undesirable effects

Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4: 'Use in patients with a history of drugs or alcohol abuse' - paragraph moved